A Hinge Flap to Reinforce Buccal Advancement Flap

NCT06066086 | Recruiting DMC

• 1 other identifier: ID: 23-24-14
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Background The chronic oroantral fistulas (COAF) is an epithelized communication that is formed between the squamous epithelium of the oral cavity and the pseudo-stratified columnar ciliated epithelium of the maxillary sinus with a high recurrent rate. The use of palatal flaps has been documented for treating such fistulae. The presence of the oroantral fistula at the area of second molars or maxillary tuberosity could complicate the use of the palatal rotational flap where the arch of its rotation is increased leading to compromised blood supply. The use of the buccal flap is not advocated because it is very thin. Rationale Double or triple-layer closure is indicated to avoid recurrence of the COAF. Different layers have been documented to minimize the risk of recurrence and reinforce buccal flaps. The oral tissues at the oral side of the oroantral fistula could used as an additional layer with buccal advancement flap and buccal fat to omit the use of palatal flap with its subsequent problems in the most posterior aspect of the maxilla Study objectives Therefore, this study will be conducted to evaluate the use of hinge flaps to reinforce the buccal advancement flap for surgical closure of the COAF in the most posterior area of the maxilla Methods The hinge flap will be performed at the oral side of the COAF to close the perforation in the sinus membrane. The oral side of the COAF will be closed with buccal advancement flap. The success rate, recurrence, time of surgery, postoperative complications, will be evaluated.

Conditions

Oroantral Fistula

Keywords

Chronic Oroantral Fistula

Outcome Measures

Primary Outcomes (3)

• Duration of Surgery

  The time elapsed from the initial incision to final closure of the flap. The time will be calculated in minutes. The mean and standard deviation will be then calculated and used to compare between the study's arms.A prolonged time means worse outcomes

  30 minutes

• Difficulties during surgeries

  Surgical difficulties scoring system will be used.Surgical difficulty was assessed by the operator using an index of 1-10 with the following divisions: 1-3 low difficulty, 4-6 intermediate difficulty, and 7-10 high difficulty. A low difficulty score means a better outcome

  60 minutes

• Recurrence of the Oroantral fistula

  The patients will be followed after surgery for the success or failure of the surgical closure. The follow-up will be weekly in the first month, and then monthly in the next three months.The recurrence means worse outcomes

  At the end of the postoperative fourth month

Secondary Outcomes (1)

• Patients' satisfaction

  At the end of the fourth month after surgery

Study Arms (2)

Hinge Flap group

EXPERIMENTAL

Patients who will be included in this study will be treated by using hinge flap and buccal advancement flap to close their oroantral fistula. A circular incision will be performed at the oral side of the oroantral fistula. The tissues will be reflected and sutured by purse sutures. Then the tissues will be pushed up to close sinus membrane. A pyramidal flap will be reflected at the buccal tissues, then horizontal incisions will be performed at the base of the flap to allow advancement of the flap over the fistula and a tension-free suturing to the palatal tissues.

Procedure: A hinge flap will be performed to reinforce the buccal advancement flap to close the oroantral fistula at the most posterior area of the maxilla

Palatal Flap group

ACTIVE COMPARATOR

Patients who will be included in this study will be treated by using he anteriorly based palatal rotational flap to close the oroantral fistula. Two paralleling incisions will be performed on the palatal side of the fistula. The distance between the two incisions will be 2 to 3 mm greater than the width of the fistula. Then the two incisions will be connected together via a circular incision at the bony end of the hard palate. The flap reflection will be performed, and the greater palatine vessels will be legated and cauterized to allow lateral repositioning of the flap over the fistula. The flap will be sutured to the buccal tissues.

Procedure: An anteriorly based palatal flap will be performed to close the oroantral fistula at the most posterior area of the maxilla

Interventions

A hinge flap will be performed to reinforce the buccal advancement flap to close the oroantral fistula at the most posterior area of the maxilla PROCEDURE

The hinge flap is raised via circular incision around the oral side of the oroantral fistula then sutured with purse suture to close the sinus membrane perforation and it is used as an additional layer that reinforce the buccal advancement flap

Hinge Flap group

An anteriorly based palatal flap will be performed to close the oroantral fistula at the most posterior area of the maxilla PROCEDURE

Two paralleling incisions will be performed on the palatal side of the fistula. The distance between the two incisions will be 2 to 3 mm greater than the width of the fistula. Then the two incisions will be connected together via a circular incision at the bony end of the hard palate. The flap reflection will be performed, and the greater palatine vessels will be legated and cauterized to allow lateral repositioning of the flap over the fistula. The flap will be sutured to the buccal tissues.

Palatal Flap group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic oroantral fistula at the most posterior area of the maxilla
• Ages above 18 years
• Patients who are medical free

You may not qualify if:

• Oroantral communications
• Absence of sinus infection
• Oroantral fistula which are resulted from tumor resections

Sponsors & Collaborators

• Qassim University: lead

Study Sites (1)

College of Dentistry, Qassim University

Buraidah, Al-Qassim Region, 1162, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Oroantral Fistula

Condition Hierarchy (Ancestors)

Oral Fistula; Mouth Diseases; Stomatognathic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ghada A khalifa, Professor

  Department of Maxillofacial Study and Diagnostic Sciences, College of Dentistry, Qassim University

  STUDY DIRECTOR

Central Study Contacts

Ghada A Khalifa, Professor

CONTACT

0096504840248; G.Khalifa@qudent.org

Suzan A Salem, Lecturer

CONTACT

00966531017409; s.salem@qu.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: October 4, 2023
• Study Start: April 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 13, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)